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| Name | Class |
|---|---|
| IQVIA Pty Ltd | INDUSTRY |
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Validation of non-inferiority between headphone amplification settings determined by a participant and settings established by audiologist best practices in individuals 18 years or older.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Self-Fit Settings | Experimental | Amplification settings established by algorithm and further adjusted by participants per their preference |
|
| Pro-Fit Settings | Active Comparator | Amplification settings established by clinical reference and further adjusted by an audiologist per current best practice |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apple Software | Device | Amplification settings established by algorithm and further adjusted by participants per their preference |
|
| Measure | Description | Time Frame |
|---|---|---|
| International Outcome Inventory for Hearing Aids (IOI-HA) Survey Results | The IOI-HA survey is a 7-item questionnaire that assesses the effectiveness of hearing aids. It was self-administered to each study participant one time at the third scheduled clinic visit approximately 18-31 days after enrollment. For each participant, the IOI-HA total score (which ranges from 7-35 where higher scores indicate a better outcome) was computed and the mean IOI-HA scores were compared between the Experimental and Reference Groups. | Approximately 18-31 days upon enrollment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IQVIA | Overland Park | Kansas | 66211 | United States |
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All 118 enrolled participants were randomized into the study
Participants were recruited from multiple sites where audiological services were provided.
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| ID | Title | Description |
|---|---|---|
| FG000 | Self-Fit Settings | Amplification settings established by algorithm and further adjusted by participants per their preference Apple Software: Amplification settings established by algorithm and further adjusted by participants per their preference |
| FG001 | Pro-Fit Settings | Amplification settings established by clinical reference and further adjusted by an audiologist per current best practice by Audiologist: Amplification settings established by clinical reference and further adjusted by an audiologist per current best practice |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Self-Fit Settings | Amplification settings established by algorithm and further adjusted by participants per their preference Apple Software: Amplification settings established by algorithm and further adjusted by participants per their preference |
| BG001 | Pro-Fit Settings |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | International Outcome Inventory for Hearing Aids (IOI-HA) Survey Results | The IOI-HA survey is a 7-item questionnaire that assesses the effectiveness of hearing aids. It was self-administered to each study participant one time at the third scheduled clinic visit approximately 18-31 days after enrollment. For each participant, the IOI-HA total score (which ranges from 7-35 where higher scores indicate a better outcome) was computed and the mean IOI-HA scores were compared between the Experimental and Reference Groups. | Posted | Mean | Standard Deviation | score on a scale | Approximately 18-31 days upon enrollment |
|
Participants were evaluated by the PI and/or designee(s) at each of the three scheduled clinic visits from the time they signed the ICF until they completed the study (approximately 18-31 days after enrollment).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Self-Fit Settings | Amplification settings established by algorithm and further adjusted by participants per their preference Apple Software: Amplification settings established by algorithm and further adjusted by participants per their preference |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest Pain | General disorders | MedDRA 24.1 | Systematic Assessment | Unspecified chest pain |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rajiv Kumar, MD | Apple | 8669055303 | htclinicalquestions@apple.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 24, 2023 | Sep 27, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 29, 2023 | Sep 27, 2024 | SAP_001.pdf |
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| by Audiologist | Device | Amplification settings established by clinical reference and further adjusted by an audiologist per current best practice |
|
Amplification settings established by clinical reference and further adjusted by an audiologist per current best practice by Audiologist: Amplification settings established by clinical reference and further adjusted by an audiologist per current best practice |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Sex at Birth | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Geographical Region of Recruitment and Enrollment | Count of Participants | Participants |
|
| Subject Medical History with >10.0% Occurrence | Medical history affecting at least 10% of study participants in any treatment group | Count of Participants | Participants |
|
| Four-Frequency Pure Tone Average Results-Full Analysis Set | Classification of the reference audiometry values averaged across four frequencies (0.5, 1, 2, and 4 kHz) | Count of Participants | Participants |
|
| OG001 |
| Pro-Fit Settings |
Amplification settings established by clinical reference and further adjusted by an audiologist per current best practice by Audiologist: Amplification settings established by clinical reference and further adjusted by an audiologist per current best practice |
|
|
| 0 |
| 59 |
| 0 |
| 59 |
| 0 |
| 59 |
| EG001 | Pro-Fit Settings | Amplification settings established by clinical reference and further adjusted by an audiologist per current best practice by Audiologist: Amplification settings established by clinical reference and further adjusted by an audiologist per current best practice | 0 | 59 | 1 | 59 | 0 | 59 |
|
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment | Painful left arm |
|
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